Summary
This is a very varied and demanding post with considerable responsibility. Senior Trial Coordinators are responsible for managing a portfolio of trials and the staff working on those projects in addition to actively coordinating trials. They are expected to contribute to the design, conduct, analysis, publication and presentation of clinical trials research. They must be able to use their own initiative, be an effective leader, team player and excellent communicator. They will usually take on a role which carries a national profile, and as such they play a pivotal role in promoting the research activity of the CRCTU and developing its external collaborative network and establishing funding contacts.
Main Duties
1. Expected to play a fundamental role in the design and preparation of new clinical trial research proposals and make a personal contribution to the CRCTU’s research activity and profile. This will include preparation of costings and grant applications, writing and editing the protocol, design of case report forms and databases used to collect research data.
2. Keep up to date with current research literature and developments in the disease site speciality and Trial Management profession. Maintain relevant bibliographies by regular literature searches and critical review. Bring ideas for innovative trials to the attention of the team’s Clinical Lead. Write literature reviews, develop and publish innovative approaches to improving trial methodology.
3. Prepare appropriate interim publications (. meeting abstracts) to maintain the research profile of the trial, and play a pivotal role in the preparation and timely completion of final research publications.
4. Keep up to date with changes in trial methodology, regulatory issues and new legislation. Help develop strategies for their implementation at team level and also national level if appropriate to the trial. Help ensure that new skills, knowledge and best practice are disseminated internally and externally to study sites if appropriate. This will involve contributing to the quality assurance programme (. by writing / approving / implementing Trials Unit Standard Operating Procedures).
5. Personally manage selected trials taking a lead in preparing and organising meetings, reports and other activities of high importance, complexity and sensitivity that require specialist knowledge or expertise. This will generally include setting-up new trials, negotiation with key external bodies, overseeing the setting-up and monitoring of clinical sites and ensuring trials are run in accordance with current legislation.
6. Take primary responsibility for ensuring that trial research data is complete and accurate. Work closely with members of the statistical team to validate the data set.
7. Responsible for management of junior staff with respect to day-to-day supervision, motivation and support of the staff (including work allocation, cover rotas, problem solving, staff development and monitoring performance). Advise and assist in the appointment and training of the junior trial management staff. Mentor, coach, and guide other members of the team as necessary.
8. Obtain appropriate regulatory and ethical approval for individual clinical trials. Ensure Standard Operating Procedures for safe conduct of trial are followed (. reporting of adverse events to regulatory authorities and Data Monitoring Committee).
9. Prepare trial progress reports as required by the regulatory authorities, ethics committees, trial Steering and Data Monitoring Committees, funding bodies and external collaborators
10. Provide first point of contact for day-today queries from study sites regarding compliance with the team’s portfolio of research protocols and provide cover for other Trial Coordinators.
11. Promotion of the team’s portfolio by the preparation of newsletters, posters and by presenting at local, national and occasionally international scientific meetings.
12. Be able to use own initiative to solve research and staffing problems.
13. Prepare standard operating procedures for the running of individual clinical trials to ensure that the research complies with current legislation.
14. Initiate and oversee the design, coding and testing of the research databases.
15. Set up clinical sites, and ensure that participating staff at these sites understand and are able to comply with the protocol and Good Clinical Practice and ensure that appropriate audit trails are being maintained in line with current legislation.
16. Monitor progress of each centre and take appropriate action to ensure good recruitment, compliance with the protocol and the quality and timeliness of the data collection. Use initiative to tackle any practical difficulties reported by clinical sites,. which affect recruitment, protocol adherence or patient safety. Conduct problem solving / quality assurance monitoring visits as required.
17. Interpret statistical data.
18. Act as a member of one or more trial management groups, responsible for the management and organisation of the conduct of clinical trial protocols and administration of the clinical collaborative groups.
19. Coordinate and support the activities of the Trial Management Group, Steering Committee, Data Monitoring Committee, and the larger collaborative group.
20. Plan expenditure against own trial budgets and negotiate with suppliers.
21. Organise and coordinate the national meetings including preparation of an appropriate agenda, obtaining sponsorship etc.
22. Lecture on relevant courses and supervise students as required.
23. Make an active contribution to setting, maintaining and communicating CRCTU policy, quality standards and trial management frameworks to junior members of staff.
24. Support the delivery of clinical research in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation (including, but not limited to, the Medicines for Human Use Clinical Trials Regulations, Data Protection Act 1998, Human Tissue Act), the Research Governance Framework for Health and Social Care, Caldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University’s Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study.
25. Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.
Required Knowledge, Skills, Qualifications, Experience
26. A higher degree (PhD or MSc) in a relevant biomedical science or associated subject with experience of clinical trials research (for some roles a proven track record of successfully obtaining research funding from a recognised funding body will suffice) or a graduate with strong experience as a Trial Coordinator and a proven ability to taken on a senior role.
27. An in-depth understanding of clinical research and trial management methodology, including applicable regulatory requirements, and a proven ability to apply these to the coordination of clinical trials
28. Experience preparing regulatory and ethics submissions, grant applications, writing and/or amending protocols, patient information sheets, Case Report Forms, reports and other relevant trial management documentation
29. Proven project management and supervisory skills
30. Excellent administrative, clerical and office management skills
31. Effective communication, negotiation, presentation and inter-personal skills
32. Excellent computing skills including advanced word processing and email. Experience in the design, maintenance and interrogation of complex relational databases (MS Access preferred)
33. Able to work on own initiative and problem solve
34. Must demonstrate a critical and intelligent attention to detail and high standards of accuracy
35. Experience preparing publications and submitting grant applications is desirable
36. Ability to meet the travel needs of the post which include travel nationally and internationally on occasion
37. Knowledge of the protected characteristics of the Equality Act 2010, and how to actively ensure in day to day activity in own area that those with protected characteristics are treated equally and fairly
Planning and organising
Senior Trial Coordinators manage a small portfolio of research projects and/or clinical trials and the individuals working on those projects. They may personally coordinate trials.
Responsibility for a particular project and member of staff will be allocated by the relevant Trial Management Team Leader. Trials are typically between 3 and 10 years duration. They follow a standard path through grant application, set-up, recruitment, follow up, analysis, closure and archiving, and the Senior Trial Coordinator’s role will vary according to the composition of the portfolio and the stage of their trial(s).
Senior Trial Coordinators will need to plan and organise their own workload, and that of staff working on their portfolio of trials. The Senior Trial Coordinator will need to be reactive as problems (. safety issues) and queries from sites and/or patients often arise with very short notice and quite frequently have to be dealt with immediately. Hence Senior Trial Coordinators have to be very organised and able to reprioritise their workload at a moment’s notice while still meeting regulatory deadlines.
Problem solving and decision making
Senior Trial Coordinators must be able to work independently and are expected to deal with most day-to-day problems (. regarding GCP compliance, non-clinical protocol queries, staffing issues) without reference to others. They must be able to use sound judgment in deciding when queries need to be forwarded onto a clinician (safety or treatment queries) or a more senior member of staff (. serious staffing problems, potential serious breach of the protocol or GCP).
They are expected to ensure staff follow the CRCTU’s quality management system and comply with the protocol, the ethical and regulatory approvals for the trial, GCP, research governance guidelines and applicable regulations.